[Federal Register: April 17, 2003 (Volume 68, Number 74)]
[Page 18988]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 03N-0009]

Agency Information Collection Activities; Submission for OMB 
Review; Comment Request; Application for Exemption From Federal 
Preemption of State and Local Medical Device Requirements

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the information collection provisions 
by May 19, 2003.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that written comments be electronically mailed 
to sshapiro@omb.eop.gov or faxed to the Office of Information and 
Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA, 
FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Peggy Robbins, Office of Information 
Resources Management (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Application for Exemption From Federal Preemption of State and Local 
Medical Device Requirements--21 CFR Part 808 (OMB Control Number 0910-

    Section 521(a) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360k(a)) provides that no State or local government may 
establish, or continue in effect, any requirement with respect to a 
medical device that is different from, or in addition to, any Federal 
requirement applicable to the device under the act. Under section 
521(b) of the act, following receipt of a written application from the 
State or local government involved, FDA may exempt from preemption a 
requirement that is more stringent than the Federal requirement, or 
that is necessitated by compelling local conditions and compliance with 
the requirement would not cause the device to be in violation of any 
portion of any requirement under the act. Exemptions are granted by 
regulation issued after notice and opportunity for an oral hearing.
    The regulations in 21 CFR 808.20 require a State or local 
government that is seeking an exemption from preemption to submit an 
application to FDA. The application must include a copy of the State or 
local requirement, as well as information about its interpretation and 
application, and a statement as to why the applicant believes that the 
requirement qualifies for exemption from preemption under the act. FDA 
will use the information in the application to determine whether the 
requirement meets the criteria for exemption in the act and whether 
granting an exemption would be in the interest of the public health.
    In addition, 21 CFR 808.25 provides that an interested person may 
request a hearing on an application by submitting a letter to FDA 
following the publication by FDA of a proposed response to the 
    FDA estimates the burden of this collection of information as 

                                 Table 1.--Estimated Annual Reporting Burden\1\
                                Numbers of    Annual Frequency per   Total Annual     Hours per
        21 CFR Section          Respondents         Response           Responses      Response      Total Hours
808.20                              3         1                           3            100            300
808.25                              3         1                           3             10             30
Total                          ............  .....................  ..............  ............      330
\1\ There are no capital costs or operating and maintenance costs associated with this collection of

     FDA based its estimates of the number of submissions expected in 
the future contained in table 1 of this document on the number of 
submissions submitted in the last 3 years and on the number of 
inquiries received
indicating that applications would be submitted in the next year. FDA 
based its estimates of the time required to prepare submissions on 
discussions with those who have prepared submissions in the last 3 

    Dated: April 10, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-9385 Filed 4-16-03; 8:45 am]